None listed
Conditions
Interventions
Intake of test food containing Plant extract for 8 consecutive weeks
Intake of placebo for 8 consecutive weeks
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese male and female participants, 40 to 59 years of age at the time obtaining consent. 2. Relatively high percentage of CD8+ T cells with high senescence-associated beta-galactosidase (SA-beta-gal) activity. 3. Have ability to consent.
Exclusion criteria
Exclusion criteria: 1. Participants who undergone surgical resection of the gastrointestinal tract (Not including appendectomy). 2. Participants who have disease that requires constant medication, or those have a serious medical history that requires medication. 3. Participants with autoimmune diseases or a history of autoimmune diseases. 4. Participants with mental illness, chronic fatigue syndrome, insomnia, or a history of such illnesses. 5. Participants who diagnosed or suspected as sleep apnea syndrome. 6. Participants undergoing treatment related to sleep, stress, and/or fatigue. 7. Night and day shift worker or manual laborer. 8. Participants who regularly taking or planning to take medicine, supplements, FOSHU, and/or food which may affect the results during the study. 9. Participants having possibilities for emerging allergy relates to the study. 10. Heavy drinkers of alcohol or excessive smokers. 11. Participants who are planning to travel abroad during the study period, or who are planning of long-term domestic trip for more than one week in study period. 12. Participants who are judged as unsuitable for the study based on the results of lifestyle questionnaire. 13. Participants who are judged as unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function. 14. Participants whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range. 15. Participants who are Participating in other clinical studies at the beginning of the present study. 16. Participants who are becoming pregnant or intend to become pregnant. 17. Participants judged as unsuitable for the study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunosenescence markers ; percentage of CD8+ T cells with high senescence-associated beta-galactosidase (SA-beta-gal) activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other immunosenescence markers ; CD3+ T cells / lymphocyte ratio, CD4+ T cells / lymphocyte ratio, CD8+ T cells / lymphocyte ratio, CD4+ T cells / CD8+ T cells ratio, percentage of CD4+ T cells with high senescence-associated beta-galactosidase (SA-beta-gal) activity, naive T cells / CD4+ T cells ratio, central memory T cells / CD4+ T cells ratio, effector memory T cells / CD4+ T cells ratio, TEMRA T cells / CD4+ T cells ratio, PD-1+ / CD4+ T cell ratio, naive T cells / CD8+ T cells ratio, central memory T cells / CD8+ T cells ratio, effector memory T cells / CD8+ T cells ratio, PD-1+ / CD8+ T cell ratio | — |
Countries
Japan
Contacts
Public ContactHiroyasu Shimada
EP Mediate Co., Ltd. R&D Support Center Foods Department Trial Planning Section 1
Outcome results
None listed